MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 595000-001

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The freedom driver was not supporting a patient.The customer, an authorized syncardia distributor, reported that the freedom driver exhibited a fault alarm at startup.

Manufacturer Narrative

Alarm history and patient data file review found four new alarms recorded in the freedom driver's alarm history indicating the driver was power cycled multiple times prior to return to syncardia.One of the fault codes observed occurs as a result of secondary motor engagement.Visual inspection of internal components found damage including a fractured bottom right housing boss and missing insert, which was found on the corresponding bolt, the secondary motor's cam follower was out of the bottom dead center position, and a small scuff mark on the main power control board assembly, all of which indicate impact shock.Visual inspection of external components revealed no abnormalities.The device passed all incoming functional testing.Additional/subsequent testing was performed on secondary system.The driver passed all functional testing.Failure investigation for this complaint confirmed the reported fault alarm.The complaint was not replicated via functional/observational testing; however, the fault alarm was able to be duplicated by forcing the secondary motor to engage during additional testing.The driver is designed to alarm when operating on the secondary motor and therefore functioned as intended.The root cause of the fault alarm could not be conclusively determined.It is likely an impact to the driver caused the secondary motor to unintentionally engage.While the freedom driver is designed to switch to operation on the secondary motor by design to mitigate risk to patient health and safety when a functional issue occurs, the driver is not intended to operate on the secondary motor and therefore alarms to alert the patient and caregivers that a driver switch is required.(b)(4).Follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 15724503
• MDR Text Key: 304967591
• Report Number: 3003761017-2022-00120
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1